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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CWRU-1Y00 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer.
OBJECTIVES:
OUTLINE: Patients receive 1 of the following preparative regimens:
All patients undergo stem cell transplantation from a matched, unrelated donor on day 0.
Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years.
PROJECTED ACCRUAL: 50
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY. |
|
| Regimen B-1 | Experimental | Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.. |
|
| Regimen B-2 | Experimental | Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY. |
|
| Regimen C | Experimental | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| busulfan | Drug | Given orally 1mg/kg/dose (or 40mg/m2/dose for young children) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Durable Engraftment | Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support. | at day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Graft-versus-host Disease (GVHD) | Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe. | at 100 days post transplant |
| Incidence of Recurrent Disease |
Not provided
Eligibility Criteria:
Patients with histologic confirmation of the following diseases are eligible:
Patients must be less than or equal to 55 years of age.
Patients (or guardians if minor) must be able to give informed consent. Children older than 11 years of age must assent to the process.
Patients or their guardians must demonstrate proof-of-payment.
Patients must have an ECOG Performance Status of 2 or less. (See Appendix I)
Patients must have no evidence of active infection at the time of transplantation.
Patients must be HIV nonreactive.
Patients must have a pre-transplant, multi-organ assessment prior to transplantation with the following outcome:
Females who are childbearing age may not be pregnant or lactating and must have a current negative pregnancy test
Ineligibility Criteria:
-Patients who have a significant psychiatric illness will be considered on a case- by-case basis. With the patient's consent, their Mental Health Care worker will assist the managing transplant physicians in determining if the patient can safely undergo transplantation and comply with followup recommendations.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Cooke, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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Thirty-five patients were recruited from local medical clinic from November 2000 through November 2009.One patient relapsed and never received a transplant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A | Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY. |
| FG001 | Regimen B-1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Regimen B-3 | Experimental | Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3. |
|
| Regimen D | Experimental | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
|
| cyclophosphamide | Drug | Given IV |
|
|
| cytarabine | Drug | Given IV |
|
|
| radiation therapy | Radiation | Patients undergo total body irradiation |
|
|
| Etoposide | Drug | infusion |
|
|
| Stem Cell Transfusion | Procedure |
|
Number of patients that have disease recurrence. |
| at day 100 post transplant |
| Toxicity as Measured by CTC v2.0 | Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities. | at 100 days post transplant |
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.. |
| FG002 | Regimen B-2 | Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY. |
| FG003 | Regimen B-3 | Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3. |
| FG004 | Regimen C | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
| FG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regimen A | Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY. |
| BG001 | Regimen B-1 | Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY. |
| BG002 | Regimen B-2 | Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY. |
| BG003 | Regimen B-3 | Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3. |
| BG004 | Regimen C | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
| BG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rates of Durable Engraftment | Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support. | Posted | Mean | Standard Deviation | days | at day 42 |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Graft-versus-host Disease (GVHD) | Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe. | Posted | Number | participants | at 100 days post transplant |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Recurrent Disease | Number of patients that have disease recurrence. | Posted | Number | participants | at day 100 post transplant |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Toxicity as Measured by CTC v2.0 | Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities. | Posted | Number | participants | at 100 days post transplant |
| ||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Number of Patients With Overall Survival at 2 Years. | Posted | Number | participants | at 2 years from transplant |
|
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other [non-serious] adverse events were not collected or assessed as part of the study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen A | Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY. | 0 | 11 | 0 | 0 | ||
| EG001 | Regimen B-1 | Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.. | 0 | 4 | 0 | 0 | ||
| EG002 | Regimen B-2 | Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY. | 1 | 3 | 0 | 0 | ||
| EG003 | Regimen B-3 | Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3. | 2 | 4 | 0 | 0 | ||
| EG004 | Regimen C | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. | 2 | 10 | 0 | 0 | ||
| EG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. | 0 | 2 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Melena/GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Elevated Bilirubin associated with graft versus host disease (GVHD) | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Memory loss | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Mood alteration-anxiety, agitation | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash/dermatitis associated with high-dose chemotherapy or BMT studies. | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Death not associated with CTCAE term - Multi-organ failure | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Cooke MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | 216-844-3345 | kenneth.cooke@uhhospitals.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D002051 | Burkitt Lymphoma |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D020522 | Lymphoma, Mantle-Cell |
| D000753 | Anemia, Refractory |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D009196 | Myeloproliferative Disorders |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D000740 | Anemia |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D007945 | Leukemia, Lymphoid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D011878 | Radiotherapy |
| D014916 | Whole-Body Irradiation |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
| OG004 | Regimen C | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
| OG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
|
|
| OG004 | Regimen C | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
| OG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
|
|
| OG004 | Regimen C | Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
| OG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
|
|
| OG004 |
| Regimen C |
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. |
| OG005 | Regimen D | Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. |
|
|